The need to increase efficiency and productivity is driving adoption.

Intensifying Downstream Processes

Effective cleaning and disinfection is imperative when operating and utilizing a cleanroom.

Cleanroom Cleaning: Proper Methodology and Determining Efficacy 

Taking key considerations into account along the cell therapy supply chain can set cell therapy developers up for success.

Establishing Consistency and Scalability of Cell Therapy Material 

Growing antibody demand requires long-term scale-up solutions.

Maximizing Long-Term Scale Up 

mRNA vaccines have led to expanded nucleic acid therapy development.

Nucleic Acid-based Therapeutics Take Spotlight 

Implementation of information gathered from novel data analysis techniques has become a priority.

The Ongoing Transformation of Process Controls

2021 brought innovations in pH sensitive antibody purification, single-use fermentation separators, and more.

What’s New in Downstream Processing?

The Janssen Pharmaceutical Companies of Johnson & Johnson announced on April 28, 2022 the submission of a Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) for the approval of niraparib and abiraterone acetate dual-action tablet plus prednisone for the treatment of patients with homologous recombination repair (HRR) gene-mutated metastatic castration-resistant prostate cancer (mCRPC).

Upon approval, niraparib and abiraterone acetate plus prednisone will be the first dual-action tablet in the European Union specifically targeting HRR gene alterations in mCRPC, according to the company. The combination is intended to be more convenient for patients and thus improve treatment compliance.

Prostate cancer is one of the most common cancers in Europe, with approximately 473,000 patients diagnosed in 2020, according to the company. Up to approximately 30% of patients with mCRPC have HRR gene alterations, which are associated with a worse prognosis compared to those without HRR gene alterations.

“People with prostate cancer harboring BRCA alterations face a more aggressive form of disease with worse outcomes and faster progression, sadly leading to a shorter life expectancy,” commented Professor Gerhardt Attard, primary study investigator and clinician scientist and team leader at University College London Cancer Institute, in a press release. “This submission is an important step towards improving the outcomes for people with metastatic prostate cancer harboring BRCA alterations using a targeted therapy that significantly delays the time to their cancer progressing.”

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Janssen has submitted a marketing authorization application to EMA for the approval of a treatment for patients with HRR gene-mutated metastatic castration-resistant prostate cancer.

Janssen Submits Marketing Authorization Application for Treatment of Metastatic Castration-Resistant Prostate Cancer

Purolite, an Ecolab company and manufacturer of synthetic and agarose-based resins, has been awarded the Queen’s Award for Enterprise in the International Trade category.

Purolite is among the 232 organizations to be recognized nationally with a Queen’s Award for Enterprise. The company was selected for its success in innovation and international trade, as well as resilience throughout the COVID-19 pandemic.

The Queen’s Award for Enterprise, established in 1965, is the United Kingdom’s highest accolade for business success. The awards, granted annually, acknowledge firms that have excelled in exporting, social or environmental good work, or innovation.

Leighton Davies, finance director at Purolite, has received an invitation to the Buckingham Palace awards reception that is to be hosted by Prince Charles.

“It’s a tremendous honor to have won the Queen’s Award for Enterprise. I’m immensely proud of this achievement and would like to thank the fantastic teams we have in place all over the world, as well as the continued support of our valued customers,” commented Hayley Crowe, SVP and general manager of Purolite, upon the company receiving the award.

Purolite has received the Queen’s Award for Enterprise in the International Trade category.

Purolite Awarded Queen’s Award for Enterprise

Vifor Fresenius Medical Care Renal Pharma (VFMCRP) and Cara Therapeutics announced on April 28, 2022 that the European Commission (EC) has granted marketing authorization to Kapruvia (difelikefalin) for the treatment of moderate-to-severe pruritis associated with chronic kidney disease (CKD) in adult hemodialysis patients.

The treatment was approved by FDA in the United States in August 2021 for the same indication under the name Korsuva. The EC approval allows the treatment to be used in all member states of the European Union, as well as Iceland, Liechtenstein, and Norway. According to the company, Kapruvia is the first approved therapy in Europe for the treatment of pruritis associated with CKD in hemodialysis patients. The first launches in Europe are expected in the second half of 2022.

“We are very excited about the European Commission’s approval of Kapruvia, marking an important milestone on our journey to advance and fundamentally change the treatment paradigm for people living with the severe burden of pruritus associated with chronic kidney disease,” said Dr. Klaus Henning Jensen, chief medical officer of Vifor Pharma, in a press release. “We look forward to bringing this first-in-class therapy to patients in Europe, with launch in first markets expected in the second half of 2022.”

“The European Commission’s approval of Kapruvia provides a much-needed therapy to hemodialysis patients in Europe who suffer from pruritus,” said Dr. Joana Goncalves, Chief Medical Officer of Cara Therapeutics. “We are excited to bring an innovative drug to physicians to help change the way pruritus is managed. We continue to work with our commercial partner VFMCRP, to fill a significant unmet medical need among CKD patients with pruritus in both the U.S. and Europe.”

Kapruvia has been approved by the European Commission for the treatment of moderate-to-severe pruritis in hemodialysis patients.

Kapruvia Approved by EC for Treatment of Pruritus

Validair announced on May 1, 2022 that it has formed a new company that has been appointed as a channel partner for Ireland by TSI Inc., a particle counter manufacturer and contamination control company. The agreement will allow Validair Monitoring Ireland Limited to deliver services across Ireland from its headquarters in Dublin. The new company will offer the entire TSI range of products and access to more than 20 field service and specialist technical engineers in the pharmaceutical, life sciences, biotech and research, and healthcare markets.

“Validair companies have demonstrated impressive capabilities with more than 120 TSI systems installed in the [United Kingdom] over the past 20 years, including the largest-ever global installation at Oxford Biomedica. We are very confident that the new venture will deliver the same excellent level of results that Validair customers in other territories have come to expect,” said Simon Tebb, sales manager EMEA Controlled Environments at TSI Inc., in a press release.

The new company has been appointed as a channel partner for Ireland by TSI Inc., a particle counter manufacturer.

Validair Launches New Company in Ireland

Standard BioTools, previously known as Fluidigm, announced the launch of the Hyperion+ Imaging System, a high-plex spatial imaging tool, in April 2022. Relative to the original Hyperion Imaging System, the Hyperion+ provides lower limits of detection, improved sample capacity, and quicker time to results.

According to an April 11 press release from the company, the system can process over 100 samples per week, approximately twice the speed of their current model. It also has a 1.6x lower limit of detection, enabling detection of dim markers, which can be important when analyzing the lower-expressing markers often used in translational studies.

The device allows for scanning of eight to over 40 targets in a single run and can easily be scaled to more than 100 targets. Additionally, by using an efficient, simple stain, image, and analyze workflow, it reduces expenses up to 10x relative to immunohistochemistry, which uses complicated cyclic immunofluorescence or digital profiling approaches, according to the release.

“Two critical challenges in realizing the full transformative potential of this remarkable technology are reducing the time to answer key biological questions and detecting important biomarkers that are expressed at low levels,” said Michael Egholm, CEO and president, Standard BioTools, in the press release. “The Hyperion+ Imaging System is designed to solve these challenges with faster time to results and a lower limit of detection than the current Hyperion Imaging System. These capabilities are key to quickly uncovering important spatial relationships with high-plex spatial imaging of 40-plus markers simultaneously at subcellular resolution.”

“My research group has been able to rapidly conduct exquisitely detailed phenotyping studies using the speed enhancements now available in the Hyperion+ Imaging System, which give us unprecedented insight into how cells within the tumor microenvironment function and interact with each other and the extracellular matrix,” said Bernd Bodenmiller, professor at the Department of Quantitative Biomedicine, University of Zurich, and at the Institute of Molecular Health Sciences, ETH Zurich, in the press release. “These insights are the foundation for innovating the next generation of cancer diagnostics and therapeutics and improving outcomes for patients with cancer.”

Standard BioTools’ new Hyperion+ Imaging System can process more samples and has lower limits of detection than their current product.

Standard BioTools Launches Hyperion+ Imaging System

Quanterix, a company specializing in biomarker analysis, announced that FDA has granted its Simoa neurofilament light chain (NfL) plasma test a breakthrough device designation. According to an April 22 press release from the company, the designation covers the devices use as a prognostic aid in assessing the risk of disease risk in patients diagnosed with relapsing-remitting multiple sclerosis (RRMS).

According to the release, the device is a digital immunoassay that quantitatively measures NfL in human serum and plasma. If used in conjunction with clinical, image, and laboratory findings, it could serve as an aid in identifying RRMS patients' risk of relapse within four years, allowing physicians to tailor an individualized therapeutic approach.

“For the more than two million people suffering from MS worldwide, there’s an important need for more informed and effective treatment options,” said Kevin Hrusovsky, chairman and CEO, Quanterix, and founder, Power Precision Health, in the press release. “Obtaining FDA breakthrough device designation for our plasma NfL MS test was a key objective for 2022. We are pleased to have the opportunity to work with [FDA] to help advance the Quanterix Simoa NfL test towards regulatory approval.”

Prior to this designation, a study from The Lancet Neurology used this plasma test to help establish a new method for identifying and interpreting values of serum NfL (sNfL) in individual MS patients. Additionally, it was referenced in at least 20 studies presented at the American Academy of Neurology’s 74th Annual Meeting.

“There has been an ever-growing body of research with the Simoa NfL blood test supporting NfL as a reliable biomarker for MS disease activity prognosis and treatment response monitoring,” said Mark S. Freedman, professor of neurology and director of multiple sclerosis research at the Ottawa Hospital, in the release. “[FDA’s] grant of [b]reakthrough [d]evice designation for this test has the potential to help the multiple sclerosis community further advance the optimal use of NfL measurements in both research and clinical practice aimed at more effective therapeutic management of the disease for the millions of patients suffering from the condition.”

This is the second test from Quanterix that FDA granted breakthrough device status—the company’s phospho-Tau 181 assay for Alzheimer’s disease also received the designation in 2021.

FDA granted Quanterix’s neurofilament light chain plasma test a breakthrough device designation as a prognostic aid for relapsing-remitting multiple sclerosis.

FDA Grants Quanterix Plasma Test Breakthrough Device Designation

 diagnostics company, recently announced new data on its Accelerate Arc Module and BC kit. Internal studies found that the kit demonstrated 94% or greater accuracy on positive blood cultures when compared to conventional matrix-assisted laser desorption/ionization (MALDI).

According to an April 25 company press release, one study seeded samples for 20 of the most prevalent organism species (totalling 100 isolates) that were incubated on a blood culture system (BD Bactec FX, BD). After flagging positive, the samples were then processed on the new ARC BC kit, and subsequently tested in triplicate on two MALDI systems (Bruker Biotyper, Bruker, and (Vitek MS, bioMérieux). The Arc-processed samples had an overall agreement of 100% with the Bruker Biotyper and 94% with the Vitek MS.

Another study, conducted with the Medical College of Wisconsin, processed 50 fresh positive blood cultures from the VersaTrek blood culture system on the Arc Module, which were subsequently tested in triplicate on the Bruker MALDI system. When comparing the results, it was found that the Arc enabled direct identification of microorganisms in 90% of blood cultures, with 100% agreement between the Arc and colony identification. Additionally, the Arc enabled identification in under 90 minutes, with less than five minutes of hands-on time.

“This data represents an important step in providing a workflow solution to help automate sample preparation for rapid and accurate microbial identification, saving hours of wait time and numerous manual steps to deliver results," said Shelley Campeau, co-author of the studies and director of Scientific and Clinical Affairs, Accelerate Diagnostics, in the press release.

Accelerate Diagnostics’ new blood culture kit demonstrated 94% or greater accuracy on positive blood cultures relative to matrix-assisted laser desorption/ionization (MALDI).

Accelerate Diagnostics Blood Culture Kit Demonstrates Increased Efficacy

 Washington Editor, jillwechsler7@gmail.com.

FDA officials have faced a range of tough questions on Capitol Hill in recent weeks as part of the process for gaining timely agreement on legislation to reauthorize user fees for the agency’s medical product regulatory programs. On April 26, 2022, members of the Senate Health, Education, Labor & Pensions (HELP) Committee quizzed Center directors for drugs, biologics, and medical devices on multiple contentious issues—expedited approvals, vaccines for young children, orphan drug exclusivity, access to medical abortions, conflicts of interest, and hiring initiatives, to name a few.

Less was said by most members of the HELP Committee about the specific provisions in the new user fee packages for drugs (PDUFA), generic drugs (GDUFA), and biosimilars (BsUFA), which were 

 by Center for Drug Evaluation and Research (CDER) Director Patrizia Cavazzoni and Center for Biologics Evaluation and Research (CBER) Director Peter Marks. A delay in finalizing the agreement on medical device user fees (MDUFA), however, drew sharp criticism from the committee’s ranking Republican, Sen. Richard Burr (R-NC). And Burr questioned whether added fee payments really will enable these key FDA operations to actually reduce sizeable staff vacancies, as new hires have failed to offset even larger attrition rates at the agency.

Several senators challenged FDA’s approval of Aduhelm to treat Alzheimer’s disease and the equally controversial decision by the Centers for Medicare and Medicaid Services (CMS) to limit access to the drug to those Medicare beneficiaries enrolled in postapproval clinical trials. Cavazzoni was adamant about the validity of FDA’s approval of the drug, while also seeking Congressional support for legislation enabling FDA to require manufacturers to start confirmatory trials at time of drug approval, to meet agreed on timelines and milestones for such studies, and for authority to expedite the market withdrawal of drugs that fail to show benefit in postapproval trials.

In response to queries about a recent court decision involving the Orphan Drug Act, Cavazzoni warned that the ruling “will send a chill” into the development of rare disease treatments, especially for children. That discussion involves the finding in the case of Catalyst vs. FDA by the US Court of Appeals in October 2021 that FDA cannot approve a pediatric version of a drug that has obtained orphan drug exclusivity for the adult version. That ruling, said the CDER director, enables a company to develop a drug for a very narrow patient population and then use the exclusivity for the initial approval to block further research on the therapy for other conditions and patients. The controversy may prompt legislative action or end up for review by the Supreme Court.

The increasingly contentious debate over FDA regulation of access to the abortion pill mifepristone also gained a hearing, as Sen. Roger Marshall (R-Kan) warned that patients will be harmed by recent changes in FDA rules that permit access to the drug through telemedicine, as opposed to requiring a visit to a doctor’s office. Marshall cited the potential for severe complications if women take the pills too late in pregnancy, which he said is more likely without an in-office ultrasound examination. Cavazzoni responded that FDA’s “exhaustive review” of the drug indicates that current procedures ensure its safe use, and that an ultrasound examination is not required. Requests for pills to terminate pregnancy have risen recently as states enact increasingly severe limits on abortions, despite parallel efforts to discourage mifepristone use. FDA’s more flexible position on the issue is expected to be a target for legislation backed by anti-abortion groups.

And in response to a query from Committee chair Sen. Patty Murray (D-Wash) about delays in access to vaccines for children under six, Marks of CBER said that FDA action on such a vaccine was a “top priority”, that the agency was waiting for manufacturers to file EUA applications, and that CBER would discuss such preventives at a public advisory committee meeting; a highly transparent discussion, said Marks, was important for building public trust in the safety and effectiveness of any preventive for very young patients. CBER’s subsequent announcement that such committee review would not occur until June 2022, however, prompted loud protests about FDA delaying access to vaccines important for keeping very young patients healthy.

The tone and scope of the questioning of FDA officials here and at earlier hearings by the House Committee on Energy and Commerce provide a glimpse of what measures Congress may tag on to the user fee reauthorization package. The outcome of months of discussion will emerge more visibly this month as the process moves forward to “mark up” a legislative proposal that includes all the user fee packages and leading add-on measures. All parties would like to see Congress vote on user fee legislation before its annual recess in August, but the schedule is tight, and the scope of pet initiatives expands every day.

Members of Congress asked FDA about multiple contentious issues, including expedited approvals, vaccines for young children, orphan drug exclusivity, access to medical abortions, conflicts of interest, and hiring initiatives. 

Congress Presses FDA on Key Policies and Operations 

The Office of Compliance in FDA’s Center for Drug Evaluation and Research has released the office’s 2021 Annual Report. The report focuses on the various successes of the agency in public health throughout 2021.

The report highlights key initiatives that had a direct impact on patient safety, including efforts to address the COVID-19 pandemic. Other areas of focus include addressing the opioid crisis, compounded drug quality, drug supply chain security, fraudulent and unsafe drugs, amongst others throughout 2021.

The Office of Compliance’s efforts regarding COVID-19 included shielding patients and consumers from unsafe, ineffective, and poor-quality drugs, including unsafe hand sanitizers and products fraudulently claiming to prevent, treat, or cure COVID-19. The office also took action to increase access to critical medicines used to treat patients with COVID-19, such as albuterol, oxygen, and propofol, as well as support the development of new therapeutics.

The use of alternative tools used when on-site inspections were prevented due to COVID-19 was also described in the report, focusing on reorganization to strengthen oversight of drug compounding and prevention of fraudulent, poor quality, and unsafe drugs. The Office of Compliance makes strategic and risk-based decisions that are guided by law and science to foster global collaboration, promote voluntary compliance, and take decisive and swift actions to protect patients.

FDA’s Office of Compliance has released its 2021 Annual Report, which highlights the agency’s successes in public health.

FDA’s Office of Compliance Releases 2021 Annual Report

Providing Submissions in Electronic Format– Postmarketing Safety Reports

, the last in a series of guidance documents intended to assist industry when making certain regulatory submissions in electronic format to FDA’s Center for Drug Evaluation and Research (CDER) and Center for Biologics Evaluation and Research (CBER).

The guidance is intended for any party with postmarketing safety reporting responsibilities for approved and unapproved human drug products and licensed biological products, excluding vaccines. The guidance also provides recommendations on how to submit postmarketing safety reports that FDA can process, review, and archive. A revised draft version of this guidance was issued in June 2014, and minimal changes were made in the final guidance.

The guidance provides general information on the electronic submission of postmarketing safety reports under the following provisions, according to FDA; “21 

] 314.80 and 314.98 (regarding products with approved new drug applications (NDAs) and abbreviated new drug applications (ANDAs), respectively, including combination products or drug constituent parts with approved NDAs or ANDAs2; 21 

 600.80 (regarding products with approved biologics license applications (BLAs), including combination products or biological product constituent parts with approved BLAs)3; 21 

 part 4, subpart B (requiring additional reports for combination products with approved NDAs, ANDAs, or BLAs); and 21 CFR 310.305 (regarding prescription drug products marketed for human use without approved NDAs or ANDAs, including prescription drug products that are compounded.”

FDA has issued the final guidance on electronic postmarketing safety reports in a series of guidance documents. 

FDA Issues Final Guidance on Electronic Postmarketing Safety Reports

Pfizer and Biohaven Pharmaceutical Holding Company announced on April 27, 2022 that the European Commission (EC) has granted marketing authorization for VYDURA (rimegepant), a calcitonin gene-related peptide (CGRP) receptor antagonist, for both the treatment of migraine with or without aura and prophylaxis of episodic migraine in adults who have at least four migraine attacks per month.

The medicine is an orally disintegrating tablet and is the first medicine to be approved for both acute and prophylactic treatment of migraine in the European Union (EU). According to the press release, approximately 1 in 10 people are living with migraines in Europe alone. Migraines disproportionally affects women by three to four times compared to men globally.

The marketing authorization follows the recommendation for approval by the European Medicines Agency (EMA) Committee for Medicinal Products for Human Use (CHMP) in February. The approval will be valid for all 27 EU member states, as well as Iceland, Liechtenstein, and Norway. Approval is expected to follow shortly in the United Kingdom.

“Today’s approval marks a huge step forward for patients in Europe who are living with migraine. Migraine is often overlooked and undertreated, resulting in substantial disability with suboptimal care for patients,” commented Professor Peter Goadsby, director of the National Institute for Health and Care Research (NIHR) Clinical Research Facility and Professor of Neurology at King’s College London. “VYDURA’s promising efficacy and favorable benefit-risk profile spark hope for people in need of new migraine treatment options. This approval has the potential to advance the standard of care for migraine in the EU and I am hopeful it will improve the quality of life for many people living with the burden of this prevalent neurological disease.”

VYDURA has been granted marketing authorization by the European Commission for both acute treatment of migraine and prophylaxis of episodic migraine. 

Migraine Treatment Granted Marketing Authorization by European Commission 

Editor of Pharmaceutical Technology Europe

As the biopharmaceutical industry grows year on year, it is becoming more pressing to improve yields and process efficiencies. A common bottleneck in downstream processing (DSP) is found in the purification and separation of the biopharmaceutical products. To learn more about purification and separation in DSP, 

 spoke with Alexei Voloshin, global application development manager at 3M Separation and Purification Sciences Division.

What are the main techniques and technologies employed for DSP separation and purification of biopharmaceutical products?

Ultimately with this downstream process, unit operations are needed to separate the biopharmaceutical product from a complex mixture of expression organism, byproducts of the organism’s metabolism and other cell waste, and then purify that product to the highest stage of purity, especially for injectables that must be safe and efficacious.

There are four main techniques for separation and purification: separation by size, typically referred to as filtration; separation by chemical property, also known as chromatography; separation by affinity, another type of chromatography, which utilizes a protein’s biological structure or function for purification (this process can be likened to a lock and key: there is set of interactions or features that must be in an exact order for a product to filter through or bind to it); separation by density, which utilizes centrifugation to separate the large, denser particles from less denser ones.

Each of these techniques is implemented by a technology solution to help the downstream process scale to a level that allows for mass production of biopharmaceuticals. These technologies include filters or chromatography devices (e.g., columns of packed, porous beads, membranes, or fibers functionalized with a special property).

These separation techniques and technologies are typically arranged in a sequence with a precise strategy as dictated by engineers or lab technicians and are chosen based on what the problem requires. Some or all separation techniques and corresponding technologies may be used in a downstream sequence.

Could you run through the key challenges of downstream separation and purification in biopharmaceutical development?

At a high-level, the industry is challenged by the need to produce exponentially more as new therapies are brought to market. Biopharmaceutical companies want to expand into new markets, which they can only do through decreasing the cost of drugs and treatments. However, this expansion is limited due to production inefficiencies.

To battle these inefficiencies, we need a qualitatively simpler downstream process with fewer steps, as well as more efficient methods to scale up and scale out of the processes. Some processes require many steps, which not only requires many different types of equipment, but also highly trained staff to operate it. The industry is working hard to improve technology and to update outdated processes that have long caused bottlenecks in DSP separation and purification.

How can companies overcome the bottleneck issues commonly associated with DSP separation and purification?

The bottlenecks in DSP separation and purification come back to inefficiencies; there are too many steps, and each individual step can be seen as a bottleneck itself. Some steps are high-performance, but some are not—they fall victim to outdated technology and processes.

To combat this, the industry collectively needs to be able to execute high-performance separation, or high-fidelity separation, at all stages of the process. For example, if you can only separate one type of impurity per one part of the process, that’s a lot of steps. But, what if we design and implement technology that helps reduce a wide range of impurities in one unit operation by cleverly managing the chemistry and physics of the separation? This approach greatly reduces the number of unit operations and makes the process more efficient and robust at the same time.

The industry is transitioning to convective technologies—such as fibrous separation media and membrane separation media—to achieve better separation at all stages of the process. The physics of these technologies is compatible with being able to separate qualitatively better, therefore eliminating or combining process steps.

Is the increasing complexity of biomolecules in the development pipeline impacting DSP purification and separation?

The increasing complexity and variety of biopharmaceutical modalities present both exciting opportunities for patients, but also challenges in building new purification platforms. For example, when insulin was being produced, it was one specific product, and the process could be improved over time. More recently, monoclonal antibodies came around, and they have minor variations across the scaffold, so scientists developed a purification platform that was improved and simplified over time. Scientists can then use this knowledge to build out platforms of emerging modalities such as viral Frankenstein molecules, nano-particle particles, viral vectors, and cells. Each platform must be able to deal with unique chemical and physical characteristics of the expression platform and the product itself.

For example, with the emergence of gene therapy, scientists have discovered we cannot use the same technologies that have been used for years for recombinant proteins. The physics backed into the purification technologies for proteins simply does not work very well on large particles used in gene therapy. With the increasing complexity of biomolecules, there is a new awareness of the fact that we need to look even closer at the physics and chemistry of these molecules to ensure the separation and purification technologies are compatible.

As sustainability and being environmentally friendly are increasingly important considerations for industry, what are the key aspects of DSP purification and separation that can be improved, in your opinion, to ensure greater sustainability or less of an environmental impact?

Efficiency is key—the more efficient we are, and with less materials used, the more we can make with less, therefore having a smaller environmental footprint. We achieve better efficiency through better technology, specifically technology that cuts down steps and makes each step smaller. For example, one of the biggest footprints in bioprocessing is the use of ultra-pure water as it takes a lot of energy to create it. If we can combine steps that perhaps cut down on the need for as much ultra-pure water, we could improve the environmental impact of the separation and purification process. These are principles of process simplification and intensification.

It also may seem counter-intuitive, but the use of single-use systems can help plants be more sustainable. It takes a lot of water and chemicals to use multi-use systems, given the incredibly thorough cleaning they must undergo between uses. Some plants use steam-cleaning for their sterilization process which also takes a lot of energy. By making small, high-performance single-use devices for the separation and purification process, the waste and energy input is much smaller compared to what it would be otherwise.

 Are there any particular trends for the future, say in the next 5–10 years, that you believe will be impactful for purification and separation in DSP?

The acceleration of process technology innovation is key to enable the next generation of manufacturing processes for the biopharmaceutical industry; specifically, technology that reduces steps in the process and is more automated.

We will also see a transition to convectionally driven separation technologies, given they have been proven to be much faster than legacy technology.

Finally, we will see more portable integrated processes, which is specified as a scalable system together with the product. When you want to scale up or to scale out, you either clone the process or use defined rules to build a bigger version of itself. This is another paradigm where single-use technologies are key as the unit operations exist as scalable units of discrete building blocks that you can readily implement anywhere. If there is a sudden need to make a mass amount of that therapeutic, like in the instance of a pandemic, you can ship the process anywhere in the world with a suitable basic facility and implement it very quickly.

An increasingly complex development pipeline and industry considerations, such as sustainability, are leading to a greater need for more efficient separation and purification in downstream processing.